Ruxandra Draghia-Akli, Director of the Health Directorate for DG Research & Innovation

In the first of a two-part exclusive, Ruxandra Draghia-Akli explains why innovation, cooperation and investment must be at the centre of the ambitious EU strategy to tackle global health challenges

To begin, could you give an overview of the Health Directorate and its mission?

My Directorate supports the research community in improving European and global health and the competitiveness of European health-related industries and businesses. Our work contributes to the achievement of the aims of a variety of EU policies, including the headline policies of Europe 2020 and the Innovation Union.

We fund excellent and innovative research through the multi-annual Framework Programmes for Research and Technological Development. Within FP7, the Seventh Framework Programme (2007–2013), Health Research has a budget of 6.1 billion euros.

The projects we fund are transnational and collaborative, meaning that FP7 Health brings together excellent teams of innovative researchers from different European and associated countries, as well as other international partners working in universities, research centres, hospitals, SMEs and large industries and associations.

The complementary range of skillsets and areas of expertise bring benefits to participants that they might not otherwise have access to: for example, projects can feature partners with expertise not only in knowledge creation and research, but also in knowledge exploitation and innovation.

The selection of projects to fund is conducted by a system of peer review, described by independent observers as an example of best practice that could also act as a model for many national research funding organisations. Our latest set of selected proposals will be added to the 564 research projects which have been already selected for funding in FP7.

FP7 has also seen the establishment of the Innovative Medicines Initiative (IMI) joint undertaking, which will receive over its lifetime a cash contribution of 1 billion euros from FP7 Health and 1 billion euros in kind from EFPIA (the European Federation of Pharmaceutical Industries and Associations) member companies. Through IMI, the European Union and the pharmaceutical industry have joined forces in order to boost investment in European bio-pharmaceutical R&D and to overcome bottlenecks in the development of innovative medicines – both goals of increasing importance given the current climate.

An example of the work done by IMI includes the unique collaboration in the area of psychiatric drug development, the NEWMEDS project (Novel Methods leading to NeW MEdications in Depression and Schizophrenia). In this remarkable and unprecedented collaboration, NEWMEDS have pooled resources to bring together data of 23,401 anonymised patients from 67 trials on 11 compounds in over 25 countries to form the single largest database of clinical trial data ever amassed in psychiatric research.

We also contribute to a Member State-driven joint initiative aiming to tackle neurodegenerative diseases. This so-called ‘joint programming’ initiative recognises the impact of neurodegenerative diseases, in particular Alzheimer’s disease, on an ageing European society, and aims to aid Member States in joining forces to establish a strategic research agenda to tackle the scientific, clinical and increasing societal challenges of these diseases which are set for a dramatic increase in prevalence.

We are also a joint funder of the European and Developing Countries Clinical Trials Partnership (EDCTP), to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in developing countries, particularly in sub-Saharan Africa. In practice, that means stepping up cooperation and the networking of European national programmes; accelerating clinical trials of new products, in particular drugs and vaccines in developing countries; helping to develop and strengthen capacities in developing countries, including the promotion of technology transfer where appropriate; and encouraging the participation of the private sector and mobilising additional funds to fight these diseases, including funds from the private sector. The EDCTP will receive a total of 200 million euros from the Sixth Framework Programme (FP6), with another 200 million pledged by Member States. A possible second EDCTP is currently under discussion with the Member States whose decision to continue the programme is just the first step in the process.

You previously served as Vice President of Research at VGX Pharmaceuticals (currently Inovio) and VGX Animal Health. What has this experience brought to your role at the European Commission? How has working as an inventor on more than 100 patents and patent applications helped you to understand and confront the issues of health research?

With the arrival of our new Commissioner, Máire Geoghegan-Quinn, the mandate of our Directorate General changed from what has been in the past ‘research’ to ‘research and innovation’. My experience in academia, in being one of the scientific founders of a small enterprise, being an inventor, and having taken new technologies from bench to commercial product has helped me better understand the needs of the scientific community and the process of innovation; consequently, I have been able to lead more efficiently and implement any necessary changes from both an organisational and thematic perspective.

What do you see as the main research priorities for the Health Directorate, and why?

This year, once again we have novel features in our work programme, including an emphasis on the participation of SMEs and on the funding of clinical trials. With the publication (19 July 2010) of our 2011 Work Programme (WP) and its corresponding calls for research proposals, we describe research topics which span the continuum from basic to translational research. Eight topics aim to support clinical trials to verify the safety and efficacy of various treatments and to promote the translation of research into clinical practice, each of which may result in several projects receiving up to 6 million euros. Successful projects will target results increasing therapeutic options for patients and will stimulate the implementation of best practice in Member States. Topics address issues as diverse as regenerative medicine, brain-related diseases, human development and ageing, antimicrobial drug resistance, cancer, cardiovascular diseases, diabetes and obesity, and off-patent medicines for children.

To what extent is the Commission recognising the potential of small and medium-sized enterprises in the European research landscape?

When you consider that the U.S. public expenditure on health research is three times as great as that of the EU Member States and FP7 combined, SMEs are crucial for the innovation strategy of the EU. SMEs are the engines for innovation and growth. Thus, in line with the research and innovation approach, the work programme also features eight SME-targeted collaborative projects, requiring the strong involvement (usually a minimum of 30 per cent) of such enterprises. In addition, two ambitious ‘high impact’ research initiatives in immunisation and in epi-genomics with up to 30 million euros of EU funding, require that 15 per cent of the contribution will go to SMEs. They address the spectrum of research from knowledge generation to translational research and product development, as well as education and training.

Until now we have 735 SME participations in FP7 health research which have received a total of 246 million euros. The policy objective of FP7 health is to contribute approximately 900 million euros to SMEs. Therefore, the 2011 WP has a strong focus on SME-targeted topics; in 2012 and 2013, WPs are expected to reinforce support for innovative SMEs. A recent survey of all participants in FP6 and FP7 projects shows that about 800 SMEs have been created in the frame of EU-funded health research since 2002. Subsequent years will see investment continuing to be directed at SMEs, but also at the priorities of brain and ageing research in particular, thereby addressing the challenges posed by an ageing European population.

Given the global health challenges we face, the need for international cooperation has never been more pressing. By what means are you extending financial support to facilitate this?

114 countries already participate in ongoing FP7 health research projects. This is 30 per cent more than in FP6. In addition to the activities undertaken by the EDCTP project discussed earlier, the Health theme of FP7 promotes cooperation with international partners with the possibility of involving partners from any part of the world – in most cases with EU funding. For example, the recent coordinated FP7-Africa-2010 call for proposals addresses research aspects of the Africa-EU strategic partnership. A number of health research projects will be funded, each featuring a minimum of two partners from African countries.

The Health theme of FP7 is open to cooperation with partners from many non-European countries. Specifically targeted cooperation with other regions of the world includes the Mediterranean, Russia, and India and may in the future feature Brazil, China, Latin America and areas with clear European and global added value. In these targeted cases, FP7 funds are occasionally, but not necessarily, set aside to fund partners from these countries directly, but funding of European partners is conditional on their cooperating with non-European researchers, following agreement between the relevant funding agencies to publish similar calls for proposals in what is known as ‘programme-level’ cooperation.

How is the Health Directorate responding to EU policy needs? Are you involved with the support and follow-up of Community policies?

As evidenced in the answers above, the Health Directorate strongly supports innovation. A recent survey of all participants in FP6 and FP7 demonstrated that EU health research grants have a significant impact on innovation. Since 2002 more than 4,000 patent applications and 60,000 publications have been generated.

Just as all countries, everywhere in the world, are confronted with health challenges, all countries potentially stand to benefit when major breakthroughs are made. As one of the world leaders in health research, how are you ensuring that you are not only encouraging international cooperation to achieve such breakthroughs, but are connected to cutting-edge research around the world? By what means do you encourage this collaboration aside from research and financial incentives? Could you provide some examples of where this has been achieved?

This is certainly true and we are actively participating in several high-level gatherings which aim at coordinating research efforts to maximise the impact. I can mention for example the group of Heads of International Research Organisations (HIRO), where health research funding agencies from several key countries meet regularly and plan common action. Furthermore, we are involved in a number of disease or technology-specific working groups where joint activities are discussed. One of our tasks is to create new such groups in areas where a substantial level of funding is needed and international coordination is lacking. As examples of such ‘programme level cooperation’ I can mention the several activities in genomics, most recently in epigenetics, and the initiation of cooperation in population research on diabetes as well as on rare diseases. In addition to these multilateral programme level cooperations, we are also pursuing bilateral cooperation with individual countries such as the BRIC countries and Mexico, Egypt and Australia. In all those cases the participating countries contribute funding to their own researchers. I believe that this is the best model for such internationally co-funded common efforts, and that the administrative and legal framework should be kept as simple as possible. We have enough red tape and bureaucracy; consequently, the focus should be on the research and its outcomes.

Please note that the European Commission is not affiliated with this publication and the opinions expressed in this interview do not necessarily reflect its position or opinion.